Methods and apparatus for ionization

ABSTRACT

Devices and systems provide methods of controlling breathable gas generation such as for a respiratory treatment and/or for controlling ionization of the gas. In an example, a controller of a respiratory treatment apparatus controls generation of a supply of ionized air. The apparatus may include a flow generator to generate a flow of pressurized breathable gas. The flow generator may be adapted for connection with a respiratory interface. The apparatus may also include an ionizer to ionize the flow of gas. The controller may be coupled with the ionizer and the flow generator and be configured to control the ionizer to programmatically change levels of ionization of the gas. Such ionized gas treatments may be suitable for helping users to sleep or improving respiratory oxygen absorption, and may be for patients with, for example, sleep disordered breathing or chronic obstructive pulmonary disease.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a national phase entry under 35 U.S.C. § 371of International Application No. PCT/AU2013/001365 filed Nov. 26, 2013,published in English, which claims priority from U.S. Provisional PatentApplication Nos. 61/777,022 filed Mar. 12, 2013 and 61/730,271 filedNov. 27, 2012, which are incorporated herein by reference.

FIELD OF THE TECHNOLOGY

The present technology relates to systems, methods and apparatus fortreating respiratory conditions such as sleep disordered breathing orrespiratory insufficiency (e.g., Chronic Obstructive Pulmonary Disease).More particularly, it relates to the ionization generation such as forionization therapy of such conditions.

BACKGROUND OF THE TECHNOLOGY

Sleep is important for good health. Frequent disturbances during sleepor sleep fragmentation can have severe consequences including day-timesleepiness (with the attendant possibility of motor-vehicle accidents),poor mentation, memory problems, depression and hypertension. Forexample, a person with nasal congestion may snore to a point that itdisturbs that person's ability to sleep. Similarly, people with SDB arealso likely to disturb their partner's sleep. One known effective formof treatment for patients with SDB is nasal continuous positive airwaypressure (nasal CPAP) applied by a blower (air pump or compressor) via aconnecting hose and patient interface. In some forms the supply of airat positive pressure is delivered to both the nose and mouth. Thepositive pressure can serve as a “pneumatic splint” so as to prevent acollapse of the patient's airway during inspiration, thus preventingevents such as snoring, apneas or hypopnoeas and in many cases, iseffective in treating central and mixed apnea.

Such positive airway pressure may be delivered in many forms. Forexample, a positive pressure level may be maintained across theinspiratory and expiratory levels of the patient's breathing cycle at anapproximately constant level. Alternatively, pressure levels may beadjusted to change synchronously with the patient's breathing cycle. Forexample, pressure may be set, at one level during inspiration andanother lower level during expiration for patient comfort. Such apressure treatment system may be referred to as bi-level. Alternatively,the pressure levels may be continuously adjusted to smoothly change withthe patient's breathing cycle. A pressure setting during expirationlower than inspiration may generally be referred to as expiratorypressure relief. An automatically adjusting device may increase thetreatment pressure in response to indications of partial or completeupper airway obstruction. See U.S. Pat. Nos. 5,245,995; 6,398,739;6,635,021; 6,770,037; 7,004,908; 7,141,021; 6,363,933 and 5,704,345.

Other devices are known for providing respiratory tract therapy. Forexample, Schroeder et al. describes an apparatus for delivering heatedand humidified air to the respiratory tract of a human patient in U.S.Pat. No. 7,314,046, which was filed on 8 Dec. 2000 and assigned toVapotherm Inc. Similarly, Genger et al. discloses an anti-snoring devicewith a compressor and a nasal air cannula in U.S. Pat. No. 7,080,645,filed 21 Jul. 2003 and assigned to Seleon GmbH.

Respiratory insufficiency affects millions of people. For patient'ssuffering from this condition, the lungs are unable to inspiresufficient oxygen or expel sufficient carbon dioxide to meet the needsof the cells of the patient's body. For example, Chronic ObstructivePulmonary Disease (“COPD”) affects approximately thirteen millionAmericans and ten million Europeans. COPD is a disease involving somedamage to the lungs. The airways and the alveoli of the lungs can losetheir elastic quality. Walls between alveoli can become destroyed orthey can become inflamed. The airways of the lungs may also produce moremucus than usual, which can restrict airflow. This damage will typicallymanifest itself in some difficulty with breathing such as dyspnea. COPDpatients typically experience coughing, with an expulsion of mucus,shortness of breath, wheezing and a feeling of tightness in the chest.Emphysema and chronic obstructive bronchitis may each be considered tobe a form of COPD. Chronic obstructive bronchitis may be characterizedby an inflammatory response in the larger airways of the lungs.Emphysema may be characterized by destruction of tissue of the lungsfrom an inflammatory response.

There is no presently known cure for COPD. There is no treatment forrestoring the airways and alveoli of the lungs of a COPD patient totheir pre-disease condition. However, treatments and lifestyle changescan help a COPD patient to feel more comfortable, continue to be activeand impede the progression of the disease.

It will be appreciated that there is a need in the art for improvedtechniques and devices for addressing the respiratory conditions ofpatients such as those suffering from SDB or respiratory insufficiencysuch as COPD.

SUMMARY OF THE TECHNOLOGY

An aspect of certain examples of the present technology relates tomethods and apparatus for controlling, generating and/or providing arespiratory treatment.

Another aspect of some examples of the present technology is theimplementation of ion generators for cleaning, generating gasflow/propulsion and/or therapy for a user's respiratory system.

A further aspect of some examples of the technology relates to methodsand apparatus for controlling, generating and/or providing an ionizationrespiratory treatment.

Another aspect of certain examples of the present technology relates tomethods and apparatus for independently controlling a setting orgeneration of a pressurized breathable gas as a respiratory treatmentand contemporaneously but independently controlling a setting orgeneration of an ionization of the breathable gas.

Another aspect of certain examples of the present technology is acontroller for an apparatus configured to programmatically controlchanges to settings for generation of a pressurized breathable gas as arespiratory treatment and for controlling changes to settings forgeneration of an ionization of the breathable gas.

In some examples of the present technology, a respiratory treatmentapparatus may be configured to generate a controlled supply of ionizedbreathable gas. The apparatus may include a flow generator to generate aflow of breathable gas at a pressure above atmospheric pressure. Theflow generator may be adapted for connection with a patient respiratoryinterface. The apparatus may also include an ionizer to ionize the flowof breathable gas at a level of ionization. The apparatus may alsoinclude a controller, such as one that includes a processor. Thecontroller may be coupled with the ionizer and the flow generator. Thecontroller may be configured to control the ionizer to programmaticallychange the level of ionization of the pressurized flow of breathable gasto set the level to a plurality of different ionization levels.

In some cases, the controller may be configured to decrease the level ofionization over a period of time. The controller may be configured toincrease the level of ionization over a period of time. The controllermay be further configured to pulse the level of ionization over a periodof time. In some cases, the controller may be configured decrease thelevel of ionization after expiration of a wake period.

Optionally, the apparatus may also include a sensor coupled with thecontroller. The sensor may be configured to detect a physiologicalcharacteristic. The controller may be configured to change the level ofionization based on the detection of the physiological characteristic.In some cases, the physiological characteristic may be detected sleep.Optionally, the controller may be configured to adjust the level ofionization based on the detection of a sleep state. For example, thelevel of ionization may be reduced upon detection of a deep sleep stateor rapid eye movement (REM) sleep state. A deep sleep state or slow wavesleep state is also known as non-rapid eye movement (Non-REM) sleepstages 3 and 4 which form the deeper part of the sleep cycle wherein thebrain emits delta wave activity. The physiological characteristic mayinclude a detected respiratory event. The detected respiratory event maybe a detected inspiratory cycle.

Optionally, in some cases, the controller may be further configured toturn on and turn off the ionizer while continuing to control the flowgenerator to generate the flow of breathable gas. The apparatus mayfurther include a filter to attract charged contaminants from theionized flow of breathable gas. The filter may be an electret filter.

Optionally, the ionizer may be located proximate to the flow generator.The apparatus may further include a secondary ionizer. The secondaryionizer may be located proximate to the patient interface. Such a dualstage or multi-stage ionization configuration may beneficially allow theinitial ionizer(s) to promote cleaning of the breathable gas andsecondary ionizer(s) to promote inhalation of ionized gas. Optionally,the apparatus may also include a humidifier. The humidifier may have agas flow input in gas flow communication to a gas flow output of theionizer.

In some cases, the ionizer may be formed by an array of ion generators.The controller may be configured to selectively activate differentportions of the array. In some cases, the processor may be configured tocontrol the flow generator to programmatically set the flow ofbreathable gas at the pressure above atmospheric pressure. Thecontroller may control the flow of breathable gas to maintain a targetventilation. Optionally, the controller may control the flow ofbreathable gas to set the pressure above atmospheric pressure toalleviate events of sleep disordered breathing.

In some cases, the apparatus may include an ion sensor to generate asignal indicative of a level of ionization of the ionized gas. Thecontroller may also be configured to control the ionizer to change thelevel of ionization based on a measure of ionization from the ionsensor.

Optionally, the apparatus may include a delivery conduit to couplebetween the flow generator and patient respiratory interface. Thedelivery conduit may have a material with a charge state to repel theionized breathable gas. Such a repulsion force may be at or along thewalls or flow surface of the air delivery conduit to prevent or reducethe ionized gas from sticking or attaching therein and thereby mayreduce resistance of the air delivery tube. This may also be considereda shear on the flow path boundary that reduces resistance. In somecases, the delivery conduit may include one or more charge elements toset a charge state of the delivery conduit (e.g., its flow surface) torepel the ionized breathable gas.

Some cases of the present technology may include a control method of arespiratory treatment apparatus for generating a controlled supply ofionized breathable gas. The control method may include generating with aflow generator a flow of breathable gas at a pressure above atmosphericpressure. The control method may further include ionizing with anionizer the flow of breathable gas at a level of ionization. The controlmethod may further include controlling, with a processor, a change tothe level of ionization of the flow of breathable gas to set theionization to a plurality of different ionization levels. In some casesof the control methodology, the change to the level of ionization may bea decrease of the level of ionization over a period of time. In somecases of the control methodology, the change to the level of ionizationmay be an increase of the level of ionization over a period of time. Instill further cases of the control methodology, the change to the levelof ionization may include pulsing of the level of ionization over aperiod of time.

Optionally, the change to the level of ionization of the methodology mayinclude a decrease of the level of ionization after expiration of a wakeperiod.

In some cases, the control methodology may further include detectingwith a sensor a physiological characteristic. In such a case, the changeto the level of ionization may be based on the detection of thephysiological characteristic such as detected sleep and/or a detectedrespiratory event such as a detected inspiratory cycle. In some suchcases, the change to the level of ionization may include adjusting thelevel of ionization based on the detection of a sleep state. Forexample, the level of ionization may be reduced upon detection of a deepsleep state and/or REM sleep state.

In some cases, the control method may further include turning on andturning off the ionizer while continuing to control the flow generatorto generate the flow of breathable gas. Additionally, the method mayfurther include filtering the ionized flow of breathable gas to attractcharged contaminants from the ionized flow of breathable gas, such aswith an electret filter. In some cases, the ionizing may be performedproximate to the flow generator and secondary ionizing may be performedproximate to a patient interface. The method may further includehumidifying the ionized breathable gas.

In some such methods, the ionizer may include an array of ion generatorsand the method may involve selectively activating different portions ofthe array. In any such cases, the processor may control the flowgenerator to programmatically set the flow of breathable gas at thepressure above atmospheric pressure. The processor may control the flowof breathable gas to maintain a target ventilation. The processor maycontrol the flow of breathable gas to set the pressure above atmosphericpressure to alleviate events of sleep disordered breathing.

In some cases, the control method may involve generating a signalindicative of a level of ionization of the ionized gas with an ionsensor. The controlling, with the processor, may then set the ionizer tochange the level of ionization bated on a measure of ionization from theion sensor.

In some cases, the method may involve repelling the ionized breathablegas with a delivery conduit. In some such cases, the delivery conduitmay be adapted to couple between the flow generator and a patientrespiratory interface and may have a material with a charge state torepel the ionized breathable gas. The material may be provided along aflow surface or internal wall of the delivery conduit. Optionally, themethod may also involve charging with a charging element the deliveryconduit such that the charging element sets a charge state of thedelivery conduit to repel the ionized breathable gas.

Some examples of the present technology may include a solid state flowgenerator such as for a respiratory apparatus for generating acontrolled supply of breathable gas. The flow generator may include aset of ionizers configured to propel a flow of breathable gas, the setof ionizers configured with a flow path adapted to couple with a userrespiratory interface. The flow generator may also include a controllercoupled with the set of ionizers. The controller may be configured toselectively activate the ionizers for propelling the flow of breathablegas.

Optionally, the set of ionizers for such a flow generator may bearranged in a serial configuration in the flow path. Moreover, thecontroller may then be configured to selectively activate an increasingnumber of the ionizers to increase propulsion of the flow of breathablegas. In some cases, the set of ionizers may be formed as an ionizersheet or in a grid configuration. Optionally, the flow path of theionizer of such flow generators may be helical and the set of ionizersmay be arranged along the helical flow path.

In some cases, the ionizer flow generator may include a sensor and thecontroller may be configured to activate a sub-set of the set ofionizers based on a signal generated from the sensor. For example, thesensor may be a flow sensor, and the controller may be configured toselectively activate a sub-set of the set of ionizers based on a measureof flow from a signal from the flow sensor. By way of further example,the sensor may be a pressure sensor, and the controller may beconfigured to selectively activate a sub-set of the set of ionizersbased on a measure of pressure from a signal of the pressure sensor.

Optionally, in some cases, the flow generator may include a neutralizer.The neutralizer may be configured to deionize the propelled flow ofbreathable gas of the flow path of the flow generator.

Optionally, the set of ionizers may include a plurality of carbon fiberbrush ion generators. Still further, the set of ionizers may optionallyinclude a plurality of honeycomb cell ion generators.

In some cases, such flow generator(s) may have a flow path with adivider. The divider may separate two or more channels and each channelmay include a set of ionizers. The channels may include an inspiratorychannel and an expiratory channel. The divider may be arranged helicallyin a cylindrical delivery tube. The divider may be configured as aground element. The divider may be configured for removably couplingwithin a delivery conduit.

Additional features of the technology will also be apparent fromconsideration of the information contained in the following detaileddescription, drawings, abstract and claims.

Any of the aspects and features of the described example embodiments maybe combined with aspects of other examples to realize yet furtherembodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

FIG. 1 illustrates example components of an ionization therapy devicefor a controlled generation of a respiratory ionization therapy;

FIG. 2 is an example methodology for a device that implements acontrolled respiratory ionization therapy;

FIG. 3 is an example graph illustrating controlled changes made toionization levels by a controller of an example respiratory ionizationtherapy apparatus of the present technology;

FIG. 4 is an another example graph illustrating controlled changes madeto ionization levels by a controller of an example respiratoryionization therapy apparatus of the present technology;

FIG. 5 is a diagram illustrating a further example ionization therapydevice suitable for use in some embodiments of the present technology;

FIG. 6 is a block diagram of a controller for a respiratory ionizationtherapy apparatus including example components suitable for implementingthe control methodologies of the present technology;

FIG. 7 is a diagram of an example ionization therapy device with activecharging element to promote gas transfer through the delivery conduit;

FIG. 8 is a diagram of an example ionization therapy device with a solidstage flow generator;

FIGS. 9a and 9b are illustrations of a flow generator implemented withcarbon brush ionizers;

FIG. 10 is an illustration of a flow generator with honeycomb shapedionizer elements;

FIG. 11 is an illustration of example components of an ionization flowgenerator formed with a helical flow configuration;

FIG. 12 is an illustration of the assembled components of the generatorof FIG. 11;

FIGS. 13a and 14a are front views of first and second flow structuresrespectively for an example helical generator having integratedionizers;

FIGS. 13b and 14b are top plan views of the flow structures of FIGS. 13aand 14a respectively.

FIG. 15 is an illustration of a patient interface and a flow generatorincluding a dual-limb delivery conduit that comprises ionizers.

FIGS. 16a and 16b are illustrations of a flow generator comprising adelivery conduit having an inspiratory channel with ionizers, anexpiratory channel with ionizers and a divider, such as a dividerconfigured as a plate.

FIG. 17 is an illustration of a flow generator comprising a deliveryconduit having an inspiratory channel with ionizers, an expiratorychannel with ionizers and a divider, such as a divider configured in ahelical arrangement.

FIG. 18 is an illustration of a flow generator comprising a deliveryconduit having an inspiratory channel, an expiratory channel withionizers and a divider. The ionizers may be arranged on both sides ofthe divider.

DETAILED DESCRIPTION

The present technology involves methods and devices for respiratoryionization therapy, such as a provision of negatively charged air.Hemoglobin is the iron-containing oxygen-transport metalloprotein in thered blood cells. Hemoglobin iron is basically a cation and thus,positively charged. Providing ionized air to a user or patient thatincludes a negatively charged oxygen component may permit improved bloodabsorption of oxygen given the positively charged hemoglobinoxygen-transport mechanism of the blood. In some cases, this improvedoxygen affinity may result in reduced need for a secondary source ofsupplemental oxygen. Such therapy may also help to disinfect bacteriaand viruses in breathable air or in the patient's lungs and may reducedegradation or inflammation of lung tissue or lung condition. Receivingionized air may also aid sleep onset. However, it may not be desirableto provide too high a level of ionization for extended periods of time.Accordingly, some apparatus of the present technology may provide acontrolled delivery of ionized air so as to set different levels ofionization during suitable times in a treatment, regime. Such treatmentmay be suitable for patients with respiratory insufficiency (RI) such aschronic obstructive pulmonary disease (COPD). However, such therapy mayalso be suitable for other users or respiratory issues, such as forexample, sleep disordered breathing, sleep apnea, or other respiratorytreatment that may involve a breathable supply of gas.

An example embodiment of a device for implementing a respiratoryionization therapy of the present technology is illustrated in FIG. 1.In the embodiment, the ionization therapy device 100 produces abreathable gas (e.g., air) with ions, such as anions. The ionizationtherapy device 100 will typically include a patient respiratoryinterface 102, a delivery tube 110, a controller 104, an ionizer 101,and a flow generator such as a servo-controlled blower 105.

The patient respiratory interface, such as a mask 108 as shown togetherwith the delivery tube 110, provides a respiratory treatment to thepatient's respiratory system via the patient's mouth and/or thepatient's nares. Optionally, the patient respiratory interface may beimplemented with a nasal mask, nose & mouth mask, full-face mask, nasalpillows, nasal cannula or tracheostomy tube.

With the flow generator, the ionization therapy device 100 can also beconfigured to generate a respiratory flow or pressure treatment towardor in the patient respiratory interface. The nature of such flow orpressure treatments may vary depending on the type of user or patienttreated. Example pressure/flow treatment will be described in moredetail herein but may be any suitable respiratory treatment therapy.

The ionization therapy device 100 may also typically include an ionizer101. The ionizer may be located in the flow path of the ionizationtherapy device 100 that generates flow toward or pressure in the patientrespiratory interface. In the case of implementation within the flowgenerator, the ionizer may either be upstream or downstream of theblower. As illustrated in the example of FIG. 1, the ionizer isdownstream of the blower. In the example, the ionizer is integrated withthe flow path of the flow generator. However, the ionizer may also beimplemented as an add-on component or module such as one that removablycouples between the delivery tube 110 and the flow generator housing. Insuch a case, the module may include a controller and/or be in electricalcommunication, such as on a communications bus, with a controller of theflow generator. Optionally, such an add-on may couple to an inlet of theblower 105. Other structural configurations may also be implemented suchas the configuration discussed in more detail herein with reference toFIG. 5.

The ionizer 101 will typically be configured to ionize the breathablegas produced by the flow generator. The ionizer may includeelectrostatically charged elements to produce either positively ornegatively charged gas ions in the pressurized air produced by theblower. In the case of the anion generator, the electrostaticallycharged elements produce the negatively charged gas ions. In someexamples, the ionizer may be an ionization generator such as a carbonfiber brush multiple ion corona discharge. However, other types ofionizers may also be implemented. One such example of a negative iongenerator is the ionizer or means for generating negative ions asdescribed in U.S. Pat. No. 4,102,654, the disclosure of which isincorporated herein by reference.

The controller 104 or processor 114 will typically be coupled,electrically, with the ionizer 101. In some cases, the ionizer 101 maybe controlled by the controller, such as with a suitable activationcircuit, to selectively increase or decrease the electrostatic charge,voltage and/or current supplied to, or to otherwise gate, the operationof the production elements (e.g., electrodes, anodes and/or diodes) ofthe ionizer so as to increase or decrease the level of ionization.Optionally, it may be controlled by powering the ionizer 101, wholly orin part, on or off at suitable times. For example, in some cases, theionizer may be formed by an array of production elements (e.g., a set ofelectrodes or electrode tube segments (cathodes and/or anodes) etc. in ahoneycomb array through which or by which air to be ionized will pass)which may each be selectively operated by the controller to increase ordecrease the level of ionization produced by the ionizer. In some suchcases, a greater number of activated production elements of the arraymay generate a higher level of ionization and a relatively fewer numberof activated production elements of the array may generate a lower levelof ionization.

Typically, the controller's programmatic operation of the ionizer willbe independent from the controller's programmatic operation of apressure/flow of a respiratory gas treatment from the blower, whenimplemented. In other words, the controller may continue to provide thepressurized flow of breathable gas treatment with the blower to apatient or user whether or not the ionizer, in whole or in part, isactivated or deactivated by a controller to ionize the breathable gas.Thus, the controller may independently make changes to the settings forgenerating the pressure or flow of gas and to the settings forionization. However, typically, when the ionizer is ionizing the gas,the controller will control the blower to generate the pressure/flow ofgas.

Accordingly, the controller 104 (such as one including a processor 114or processors) may be configured to implement particular programmaticcontrol methodologies such as the flow/pressure gas treatment controlalgorithms and/or the ionization control algorithms described in moredetail herein. Thus, the controller may include integrated chips, amemory and/or other control instruction, data or information storagemedium. For example, programmed instructions encompassing such a controlmethodology may be coded on integrated chips in the memory of thedevice. Such instructions may also or alternatively be loaded assoftware or firmware using an appropriate data storage medium. With sucha controller or processor, in addition to methodologies for pressureand/or flow control, the ionization therapy device can be used forsetting different ionization levels, setting or changing the ionizationlevels at certain times and/or setting or changing ionization levels inresponse to detected conditions. Thus, the processor may control thelevel of ionization, for example, as described in the embodimentsdiscussed in more detail herein with reference to FIGS. 2, 3 and 4.

In some cases, the ionization therapy device 100 may also optionally beequipped with one or more sensors. For example, it may optionallyinclude a flow sensor 107 and/or a pressure sensor 106, which may becoupled with the patient respiratory interface. The flow sensor maygenerate a signal representative of the patient's respiratory flow. Thesignals from the sensors may be processed to detect obstructive orcentral apneas, hypopneas, hypoventilation, hyperventilation,cardiogenic airflow, respiratory rates, respiratory cycles, respiratoryphase (e.g., inspiration and/or expiration) and other respiratoryrelated parameters from the signals measured by the sensors. In someembodiments, flow proximate to the mask or delivery tube 110 may bemeasured using a pneumotachograph and differential pressure transduceror similar device such as one employing a bundle of tubes or ducts toderive a flow signal f(t). Alternatively, a pressure sensor may beimplemented as a flow sensor and a flow signal may be generated based onthe changes in pressure. The pressure sensor 106 may be a pressuretransducer. Although the pressure or flow sensors are illustrated in ahousing of the controller 104, they may optionally be located closer tothe patient, such as in the mask or delivery tube 110. Other devices forgenerating a respiratory flow signal or pressure signal may also beimplemented. For example, a motor RPM sensor may be utilized to estimatepressure or flow information supplied by the flow generator device basedupon the characteristics of the system. One such example is the devicedescribed in U.S. patent application Ser. No. 12/294,975, filed Oct. 30,2008 and PCT/AU05/01688, the entire disclosures of which areincorporated herein by reference.

In some cases, an ionization device 100 of the present technology mayinclude one or more ion sensors such as an ion, meter, anion sensor etc.The sensors may be located for example, proximate to the patientinterface (e.g., in or at the mask) and/or proximate to each iongenerator. The controller may detect or measure the level of ions oranions in the breathable gas generated based on a signal from one ormore of such sensor(s). In some cases, the controller may increase ordecrease ion generation by control of the ion generator(s) based on asignal from the sensor(s) that may be indicative of the level ofionization. For example, it may control ionization so that the measureis servo-controlled to satisfy a desired or set target level ofionization. Thus, the control of the ion generator(s) may optionally beby closed loop control.

Optionally, the ionization therapy device 100 may also includeadditional diagnosis sensors 112 that may assist in the setting oftreatment of the present technology. For example, the device may includean oximeter. The oximeter may generate a signal representative of ablood oxygen level of a patient. A suitable example oximeter or monitordevice may optionally be any of the devices disclosed in InternationalPatent Application No. International Application No. PCT/AU2005/001543(Pub. No. WO/2006/037184) or International Patent Application No.PCT/AU1996/000218 (Pub. No. WO/1996/032055), the disclosures of whichare incorporated herein by cross-reference. As disclosed in theseincorporated PCT applications, the monitor may serve as diagnosissensors that can also optionally provide a blood pressure and/or heartor pulse rate monitor for measuring a heart rate and/or blood pressureof the patient.

For example, the sensors may be configured to provide an indication ofthe resistance of the lungs. A measure of the resistance of the lungsmay provide an indication of a reduction or increase in inflammation ofthe lungs indicating a level of patient improvement or worsening. As aresult of the indication of the level of patient improvement orworsening adjustments in the therapy may be made by the controller.

In some embodiments, the diagnosis sensors may also include anelectrocardiography (ECG) monitor. Such a device may be configured todetect cardiac-related characteristics such as a heart rate and may alsodetermine respiratory events (such as central or obstructive apneas,hypopneas, etc.) Optionally, these parameters may be determined by theanalysis algorithms of controller 104 based on transmission of the ECGdata to the controller or they may be determined by the monitor and betransmitted to the controller 104.

In some cases, ionization treatment device may include sensors fordetecting sleep such as Electroencephalography (EEG) sensors. It mayinclude a sleep monitoring system such as that of BiancaMed Limiteddescribed in U.S. Patent Application Publication No. 2009/0131803,published on May 21, 2009, the entire disclosure of which isincorporated herein by reference. This BiancaMed Limited system is asleep monitoring system that includes an ECG device and a respirationinductance plethysmogram which monitor cardiac activity and physical(ribcage) respiration respectively. The ionization treatment device mayalso include contact and non-contact biomedical sensors such as any ofthe sensors described in United States Patent Application PublicationNo. 2009-0203972, filed Nov. 26, 2008, the entire disclosure of which isincorporated herein by reference. Such a non-contact monitoring sensormay transmit and then process reflected radio frequency signalsreceived, such as ultrawideband radio-frequency signals, so as to detectbodily movement, respiration and/or cardiac activities for assessment ofsleep and sleep transitions (e.g., asleep or awake detection) as well asrespiratory events (e.g., apnea, central apnea, obstructive apnea,hypopnea, etc.).

In some embodiments, the diagnosis sensors may include other movementsensors. For example, a suprasternal notch sensor or chest band may beimplemented to generate a movement signal that is indicative of patienteffort during respiration. Other suitable sensors may include themovement sensing devices disclosed in International Patent ApplicationNo. PCT/AU1998/000358 (Pub. No. W01998/052467), the disclosure of whichis incorporated herein by cross-reference. The movement sensors thus mayprovide a measure of patient effort and/or respiration rate and may beused as an alternative to a flow sensor or in conjunction with othersensors in the determination of physiological characteristics.

Based on sensor signals, such as flow f(t) and/or pressure p(t) signals,the controller 104 with one or more processors 114 may, in addition toionization control signals, also generate blower control signals. Forexample, the controller may generate a desired pressure set point andservo-control the blower to meet the set point by comparing the setpoint with the measured condition of the pressure sensor. Thus, thecontroller 104 may make controlled changes to the pressure delivered tothe patient interface by the blower 105. Optionally, such changes topressure may be implemented by controlling an exhaust with a mechanicalrelease valve (not shown) to increase or decrease the exhaust whilemaintaining a relatively constant blower speed.

With such a controller or processor, the apparatus can be used for manydifferent pressure treatment therapies, such as the pressure treatmentsfor sleep disordered breathing, Cheyne-Stokes Respiration, obstructivesleep apnea (e.g., CPAP (continuous positive airway pressure), APAP(automatic positive airway pressure), Bi-Level CPAP, CPAP withexpiratory pressure relief), nasal high flow air therapy (HFAT) etc., orcombinations thereof by adjusting a suitable pressure or flow deliveryequation. In some examples, an automated pressure adjustment therapy forsleep disordered breathing may be delivered by the methodologiesdescribed in U.S. Patent Application Publication No. US-2011-0203588-A1,published on Aug. 25, 2011, the entire disclosure of which isincorporated by reference. By way of further example, the pressuretreatment therapies of the devices described in U.S. Pat. Nos.6,532,957, 6845,773 and 6,951,217, which are incorporated herein byreference in their entireties, may be implemented with the ionizationtherapy device 100 of the present technology. For example, as describedin these patents, the controller and flow generator may be configured toensure delivery of a specified or substantially specified targetventilation, for example, a minute ventilation, a gross alveolarventilation or an alveolar ventilation, to the patient interface duringthe course of a treatment session by comparing an measure of ventilationwith the target ventilation; or delivery of a tidal volume by comparinga measure of tidal volume with a target tidal volume. This may beaccomplished with pressure variations that provide a bilevel form oftherapy or some other form of therapy that may more smoothly replicatechanges in a patient's respiration cycle.

Accordingly, the signals from the sensors may be sent to the controller104. Optional analog-to-digital (A/D) converters/samplers (not shownseparately) may be utilized in the event that supplied signals from thesensors are not in digital form and the controller is a digitalcontroller. Based on the signals from the sensor(s), the controllerassesses the changing condition of the patient or user in controllingthe settings of the device.

The controller may optionally include a display device 116 such as oneor more warning lights (e.g., one or more light emitting diodes). Thedisplay device may also be implemented as a display screen such as anLCD. Activation of the display device 116 will typically be controlledby the controller. The display device may be implemented to visuallyshow information to a user of the ionization therapy device 100 or aclinician or physician, such as historic profiles of time versesionization level graphs from one or more treatment sessions, or manualsettings to be entered as data to the controller for setting suchprofiles. The display device 116 may also show a graphic user interfacefor operation of the device. User, clinician or physician control of theoperation of the ionization therapy device 100 may be based on operationof input switches 118 that may be sensed by the controller or processor.

Optionally, the controller may also include a communications device 120for receiving and/or transmitting data with ionization therapy device100. For example, the communications device may be a wirelesstransceiver such as Bluetooth or WIFI transceiver. The communicationsdevice may also be a network, communications device such as a phonemodem and/or network card and may be implemented to send messages viathe internet directly or through a computer to which the detectiondevice may be docked. In general, the communications device 120 may beused to transmit messages or data to other clinician or physicianassessable apparatus such as a multi-patient monitoring system thatallows a physician to review data from the ionization therapy device 100serving as a remote patient data recording devices. In these systems, adatabase may be provided to record historic ionization data, such as theprofiles provided and the levels of ionization provided over time withthe device. Such data may be provided in association with datarepresenting timing of other detected physiological characteristics(e.g., respiratory events or sleep state) as described in more detailherein. Physicians or clinicians may receive a report with such use andevent data recorded by ionization therapy device 100.

One example methodology or algorithm of the controller 104, or one ormore processors, of the ionization therapy device 100 is illustrated inthe flow chart of FIG. 2. In process 200, the ionization therapy device100 may generate a pressurized flow of breathable gas. The pressurizedflow of breathable gas may also be directed to a patient interface fordelivery to a patient. As previously mentioned, the processor mayservo-control the flow generator to deliver a pressure support treatmentthat satisfies a target ventilation, for example. Optionally, such atreatment may encompass a positive airway pressure treatment (e.g., aCPAP or bi-level) to treat upper airway issues so as to treat sleepdisordered breathing.

During at least some portion or portions of such a flow or pressuretreatment control process, in process 202, the ionization therapy device100 will ionize the flow of breathable gas to a set level of ionization.For example, based on one or more signals from the controller 104, theionizer 101 will produce negatively charged gas ions within thepressurized flow of breathable gas produced by the blower, thusproducing an ionized flow of breathable gas.

Based on the control algorithms implemented in the controller 104, theionization therapy device will then control changes to the level ofionization of the breathable gas in process 204. For example, thecontroller may be configured to adjust the level of ionization so as topromote sleep. In one such example, the controller may implement atherapy session (e.g., a sleep period or night of use with the device)so as to provide a level of ionization during the beginning of thetherapy session or while the user or patient is likely to be awake butchange the ionization production level thereafter (e.g., increase,reduce or cease) when the user or patient is likely to be asleep. Such acontrol methodology may be programmatically implemented in various ways.

In one example, the controller may implement a timed wake period, suchas with a timer or countdown timer or other event detection, that beginswith the start of the pressure or flow treatment process of theionization therapy device 100. Optionally, such a timed wake period maybegin with activation of a user interface control (e.g., an ionizationstart button) by a user desiring to go to sleep or back to sleep. Stillfurther, it may begin as a function of detected events such as eventsdetectable from one or more signals of one or more sensors of theionization therapy device 100, such as an intelligent start feature. Insuch a case, the controller of the treatment apparatus may be configuredto detect a pressure or flow change at the patient interface by analysis(e.g., comparison of a measure from a signal with a threshold) of asignal from a pressure or flow sensor so as to detect when a patientinitially breaths into the patient interface after putting it on theirface. Upon such a detection, the controller may activate the ionizer tobegin ionization at a pre-set level.

During the timed wake period, the ionization level may be delivered at afirst level, e.g., an initially high level. For example, the ionizer maybe controlled such that all production elements are operating andproducing at full capacity. When the timed wake period ends, thecontroller may then adjust a setting of the ionization level. Forexample, when a pre-set time of the timed wake period lapses (e.g., atimer of the controller reaches a pre-set threshold or a countdown timerreaches zero), the controller may then automatically change theionization level (e.g., reduce the ionization level to a seconddifferent level or automatically discontinue the ionization level orbegin an oscillation of ionization levels). For example, the controllermay deactivate a subset of the production elements of the ionizer whileleaving others active and/or may reduce a voltage level of some or allof the production elements such that fewer ions are produced.

The duration (e.g., the amount of time) of the timed wake period and/orthe ionization settings (e.g., the first level (e.g., 100% production)during the timed wake period and second level (e.g., 25% production)after the timed wake period) may be pre-set by a clinician or physician.Typically, the duration of the timed wake period may be a time duringwhich it takes a patient or user to fall asleep once the use of thedevice is initiated. In some such cases, the duration may be a time inthe range of approximately 30 minutes to 60 minutes, or some othersuitable time.

In some cases, the end of or the duration of the timed wake period maybe a function of detected events such as events detectable by thecontroller from one or more signals of one or more sensors of theionization therapy device 100. For example, the end of the timed wakeperiod may be based on a detection of one or more patient respiratorycycles. For example, the duration may be a respiratory cycle countdetermined by signal analysis of a signal from a sensor. In some suchcases, by analysis of a signal from a flow or pressure sensor, thecontroller may detect patient or user inspiration (e.g., any known cycledetection methodology). A number of such detected inspiratory cycleevents may be counted beginning with the start of the timed wake period.When the counted number reaches a pre-set threshold number, thecontroller may then end the timed wake period and adjust the setting ofthe ionization level generated by the ionizer (e.g., increase,oscillate, reduce or stop). In some such cases, the duration may be acount in the range of approximately 360 cycles to 720 cycles, or someother suitable cycle count.

In some cases, the detected end of the timed wake period may be anotheranalysis of respiration. For example, by analysis of a signal from asensor, such as a flow sensor, effort sensor or other non-contactsensor, the controller may determine a respiratory rate. When therespiratory rate falls below a pre-set threshold rate, such as oneindicative of sleep, and, optionally, stays below that rate for apre-set period of time (e.g., approximately 5 to 10 minutes), the timedwake up period may be ended by the controller and the controller maythen change the setting of the ionizer (e.g., lower or cease the levelof ionization). In some cases, the threshold respiratory rate may beautomatically determined. For example, the controller may determine anaverage respiratory rate during an initial period of use (e.g.,approximately 2-5 minutes) of the device, which may then be taken as thethreshold rate for the change in ionization.

In some examples, the timed wake period may be established based on adetection of a sleep state by the controller. For example, any knownmethod for sleep detection, arousal detection or sleep state detectionmay be employed with any sensors coupled with the controller of thedevice. Such detection methodologies may include, for example, thedetection methodologies described in United States Patent ApplicationPublication No. 2009-0203972, filed Nov. 26, 2008, the entire disclosureof which is incorporated herein by reference. Additional examples ofsuch detection methodologies are described in U.S. patent applicationSer. No. 13/383,341, filed on Jan. 10, 2012, the entire disclosure ofwhich is incorporated herein by reference. In some such examples, thetimed wake period may be initiated or re-initiated upon detection ofarousal from sleep or an awake sleep state. Similarly, the timed wakeperiod may end upon detection of a sleep state (e.g., REM or a stage ofnon-REM sleep) by the controller. For example the level of ionizationmay be reduced or ended upon detection of a deep sleep state, such asstage 3 or 4 Non-REM sleep, and/or upon detection of REM sleep. Thelevel of ionization may be increased or recommenced upon detection of anawake state and/or a light sleep stage, such as stage 1 Non-REM sleepstate and/or a stage 2 Non-REM sleep.

In some cases, the provision of ionized gas may be controlled inaccordance with additional detected physiological events or conditions.For example, in response to an analysis of a signal from an oximeter,the controller may activate or deactivate the ionizer or raise or lowerthe level of ionization during control of a pressure/flow respiratorytreatment. In some such cases, an analysis of a blood oxygen level, suchas based on a comparison of a threshold, may serve as a trigger to thecontroller to change the set level of ionization provided by theionizer. For example, if the blood oxygen level falls below a threshold,the controller may initiate or increase the set level of ionization.Such an ionization level may be delivered for a pre-set period of time.By way of further example, if the blood oxygen level rises above athreshold the controller may terminate or decrease the set level ofionization provided by the ionizer. Such a test may also serve toterminate any of the periods of ionization treatment described herein.

Similarly, the controller may be configured to detect events of sleepdisordered breathing (SDB) including, for example, apnea, hypopneaand/or hypoventilation, such as by an analysis of a signal from a flowsensor. Examples of such detection methodologies are disclosed in U.S.patent application Ser. No. 12/781,070, filed on May 17, 2010 and PCTPatent Application No. PCT/AU2012/000270, filed on Mar. 15, 2012, theentire disclosures of which are incorporated herein by reference. Inresponse thereto, or in response to detection of a pre-set number ofsuch events of SDB, the controller may similarly control an increase inthe level of ionization, or start ionization, for a period of time.

In some cases, an analysis of a signal from the flow and/or pressuresensor may serve to deactivate operation of the ionizer. For example, bycomparing a pressure signal with a threshold, it may be determined thata low pressure condition exists such that the patient interface or maskis no longer being worn by the user or patient. In such a detected case,the controller may deactivate the ionizer. Similarly, if the controllerno longer detects a patient respiratory cycle after a period of time,such as from an analysis of a flow signal from a flow sensor, thecontroller may similarly deactivate the ionizer.

To ensure a limited operation of the ionizer, in some examples, thecontroller may additionally enforce a safety maximum use limit that mayoverride the controlled timed wake period or other controlled activationof the ionizer. For example, while the ionizer may be controlled toprovide an ionized gas treatment at certain levels and do so inaccordance with detected events from an analysis of signals from one ormore sensors or initiation by a user activated button, the controllermay further monitor the time of operation and/or the levels of operationof the ionizer. If the ionizer exceeds any pre-set maximum safety timelimit of operation or pre-set maximum time at certain levels ofionization during some treatment period (e.g., one nights use) with thedevice, the controller may automatically shut down the ionizer andautomatically prevent any further or continued operation of the ionizeruntil a pre-set shut down time limit has passed (e.g., a period of 12hours has lapsed, etc.). In the event of such a shutdown by thecontroller, the controller of the flow generator may neverthelesscontinue operation so as to continue to control the blower to provide aflow or pressure respiratory treatment to a patient or user but doing sowithout permitting the ionization of the breathable gas by the ionizer.

A signal graph illustrating an example controlled operation of theionizer of an ionization therapy device 100 is illustrated in FIG. 3. Attime T0, an operation of the ionization therapy device 100 may begin,such as the device producing a pressurized breathable gas from theblower and/or detecting conditions with one or more sensors. During thistime, the ionizer 101 may be deactivated by the controller or, asillustrated, the ionizer may be activated at an initial low level. Attime T1, the controller may increase (or initiate) ionization such as byincreasing the ionization level. This may correspond to the start of atimed wake period or other detected condition as previously discussedfor initiating or increasing ionization. The controller may thencontinue to control the ionizer to operate at an ionization level (e.g.,a maximum level) until time T2. Time T2 may correspond to an end of thetimed wake period or another detected condition as previously discussedfor reducing the ionization level. At this time, the controller maygradually change the ionization level, such as by ramping down theionization level to a lower level at time T3, the lower ionization levelat time T3 may or may not be the same as the ionization level providedduring time T0. The controller may then continue to operate the ionizerat the lower level until time T4, which may correspond with an end of atreatment session with the device, such as the end of the night, or thecontroller determining that the safety maximum use limit has beenreached. Although a smooth ramping of the ionization level isillustrated between times T1 and T2, and a single step is illustratedbetween times T0 and T1, the controller may optionally be configured tocontrol each of these changes to the ionization levels, as well as othersuch changes described herein, in a plurality of steps. Also the changefrom times T0 to T1 may include a ramping up to a predetermined level ofionization rather than a single step increase to the time T1 level ofionization as indicated in FIG. 3.

A further signal graph illustrating another example controlled operationof the ionizer is illustrated in FIG. 4. The graph illustrates acontrolled oscillation of the level of ionization by the controller. Inthis example, sinusoidal pulses of the ionization level may becontrolled. However, other variations of the ionization levels may beimplemented, e.g., square wave pulses, etc. In such cases, theionization oscillation may vary between a higher ionization level and alower ionization level. As a result, the controller may vary the levelsover a time period, such as a night's treatment session. Alternatively,the oscillation may vary between an ionization level at the pulse peakand no ionization (e.g., ion generator off) at the pulse trough. Suchpulses may be initiated upon completion of the timed wake period. Theperiod for each wave may be set based on any desired timing for pulsingthe ionization level. In some cases, the pulses may be generatedsynchronously with detected respiration. For example, the level ofionization may increase during inspiration (e.g. to a first ionizationlevel) and decrease during expiration (e.g., to a second ionizationlevel or alternatively, may be turned off so as to provide no ionizationlevel during expiration. In such cases, the controller may detectinspiration by analysis of a signal from a flow sensor and trigger theincrease in level of ionization in response thereto and may detectexpiration by analysis of the signal and decrease the level ofionization in response thereto. In still further cases, the pulses maybe out-of-synch with patient respiration. For example, a pulse mayextend over several breathing cycles (e.g., a peak ionization level thatextends longer than a single breathing cycle or two or more cycles).

In some configurations, the ionization therapy device 100 may beimplemented with multiple ionizers 101 located in different portions ofthe breathable gas flow path FP of the device. The ionization therapydevice 100 may include an array of ion generators for example 2, 3, 4 ormore ion generators that may be controlled to ionize the flow ofbreathable gas at the same time or separately according to differentprofiles. One such example is illustrated in FIG. 5. The figureillustrates symbolically the flow path (FP) of the ionization therapydevice 100. In this regard, ionization therapy device 100 may havecomponents similar to that of the device illustrated in FIG. 1. Ambientair may be drawn in by the servo-controlled blower 105 through an inletthat may include an optional filter 520, such as a particulate airfilter or High-Efficiency Particulate Air (HEPA) filter, to removeparticles from the air so as to clean the air. The blower 105 may thenexpel pressurized air into the path of a first ionizer 101-A that isalso controlled by a controller (not shown). The ionized air may thenpass through or across a ground element 522, such as a grounded filteror electret filter. Any remaining pollutants or contaminants in the airthat are charged by the ionizer 101-A may then be captured by the groundelement 522 so as to purify the air and thereby prevent chargedcontaminants from entering the user or patient's respiratory system. Insome cases, the charging by the ionizer destroys light bodies, such asbacteria or viruses, which are then captured by the ground elementfilter (e.g., anode or cathode). The ground element may be an array,grid or mesh filter that may be removable for maintenance (e.g., routinewashing to remove captured particles.) Optionally, the cleaned andpurified ionized air may then pass through a humidifier 524 to warm andhumidify the air. In some cases, the ground element 522 may beintegrated with the humidifier, such that a component of the humidifierserves as the ground element. The pressurized humidified ionizedcleaned/purified air may then pass through the delivery tube 110 towardthe mask or other patient respiratory interface. Optionally, the flow ofhumidified cleaned ionized air may pass through a supplemental orsecondary ionizer, e.g., ionizer 101-B, that may be located near orwithin the mask or patient interface 108. Such a supplemental ionizer,being more proximate to the user, may help to ensure that the gas ischarged (e.g., negatively) for patient inhalation.

In some cases, the delivery conduit or delivery tube 110 of a flowgenerator may be configured to promote flow of charged gas for patientinhalation (e.g., reduce flow impedance) and may thereby help to permitcharged air to be inhaled by the user/patient. For example, the materialof the conduit may be chosen so that its flow surface (e.g., interiorconduit wall) may have a shear to repel the charged treatment gas. Forexample the walls of the conduit may be formed of a material that has acharge the same as the charged treatment gas to repel the chargedtreatment gas and reduce resistance through the conduit. In the case ofanion gas therapy, the conduit may be formed of a material having anegative charged state. For example, the delivery conduit may be formedof polyurethane, polyethylene, polypropylene, vinyl (pvc), silicon,teflon and/or silicone such as silicone rubber.

The use of material forming charged walls of the conduit also preventsthe walls of the conduit from having the charged treatment gas fromattaching or grounding upon the walls of the conduit. This arrangementmay enable the secondary ionizer 101-B to be located closer to the flowgenerator, such as at the flow generator end of the conduit.

Still further, in some cases, the delivery conduit may employ one ormore elements to more actively charge the conduit to repel the chargedgas from attaching to the walls of the conduit for a reduced flowimpedance. For example, for an anion gas therapy, the delivery tube 110,such as the example illustrated in FIG. 7, may employ one or more tubesheet anodes 711, such as anodes formed cylindrically around an exterioror interior of the delivery conduit surface. Such tube sheet anodes maybe positioned in series along the tube length to negatively charge theconduit surface of the flow path.

In all other aspects the device 100 illustrated in FIG. 7 is similar tothat shown in FIG. 5. The device may include an optional filter 520, ablower 105 and a first ionizer 101-A that are controlled by a controller(not shown), a ground element 522, such as a grounded filter or electretfilter and optionally a humidifier 524 to warm and humidify the air. Insome cases, the ground element 522 may be integrated with the humidifieras described above. The pressurized humidified ionized cleaned/purifiedair may then pass through the delivery tube 110 comprising the one ormore tube sheet anodes 711 toward the mask or other patient respiratoryinterface. Optionally, the flow of humidified cleaned ionized air maypass through a supplemental or secondary ionizer, e.g., ionizer 101-B,that may be located near or within the mask or patient interface 108.

As previously mentioned, the ionization therapy device 100 can beconfigured to generate a respiratory flow or pressure treatment towardor in a patient respiratory interface in many different therapy forms(e.g. high flow treatment, CPAP, Bi-level pressure treatment, etc.). Insome such cases, it may do so without a blower. For example, one or moreion generators may serve as a solid-state flow generator (FG) to propela flow of breathable gas. In such a case, the controller may controloperation of the ion generator(s) to regulate or control (e.g., increaseor decrease) a level of flow or pressure of gas induced by ionization ofthe gas at or near the anodes or cathodes of the ion generator. As such,the flow generator of a respiratory apparatus may be implementedsubstantially without moving components. Moreover, the power consumptionof such a device may be generally lower than power consumed for atypical blower (e.g., motor and impeller) implemented flow generator.For example, such a device when implemented for a high flow air therapy(HFAT) may have a much lower power consumption compared to a typicalblower-implemented flow generator. Similarly, such a device whenimplemented for a continuous positive airway pressure (CPAP) may have abetter/lower power consumption when compared to a typicalblower-implemented flow generator. Generally, when compared totraditional blower control circuit configurations, such powerconsumption reductions for the solid state flow generators may beachieved through significantly lower current use circuits, though withpotentially higher voltage use. The lower power consumption may includea reduction in power consumption of more than 50%, 60%, 70%, 80% or 90%of the power usage compared to a typical blower implemented flowgenerator.

In some cases, the ionization therapy device may be configured to beportable, for instance suitable to be worn or carried by the patient.Since the ionization therapy device may consume lower power thantraditional blower-implemented flow generator, it may be particularlysuited for a portable configuration. In one arrangement of a portableconfiguration, the ionization therapy device may include a disposableground element. In one arrangement, the disposable ground element may beintegrally constructed with a delivery tube to form a disposabledelivery tube. Alternatively, the disposable ground element may beremovable from the ionization therapy device, such as removable from thedelivery tube, or removable from the body of the ionization therapydevice, so that the disposable ground element may be replaced asrequired.

Over the course of operation of the ionization therapy device,particulates or contaminants may accumulate on the disposableelement/component and necessitate replacement at periodic interval. Insome forms, the ionization therapy device may include an indicator toimprove identification of a disposable component that is due forreplacement, such as the disposable ground element or the disposabledelivery tube. One such indicator may include a color element toincrease contrast between conditions of disposable components, (e.g.,between a ‘new’ condition and a ‘to be replaced’ condition for thedisposable component. For example, the disposable ground element mayinclude an indicator surface that is visible to the patient or thecaregiver that is colored in a bright color such as yellow. Over thecourse of operation of the ionization therapy device, accumulation ofparticulates on the indicator surface may change its appearance toindicate that the disposable ground element is due for replacement. Theionization therapy device may also comprise a color reference guide insome cases for the patient to use for comparison to the indicatorsurface. Alternatively, the indicator may include a light sensorconfigured to determine the condition of the disposable component. Inone form, the light sensor may be configured to receive light from alight source that is reflected from a surface of the disposable element.The magnitude or quality of light received by the light sensor may varyaccording to the condition of the disposable component. In onearrangement, as the disposable component, such as the disposable groundelement, collects contaminants, the amount of light captured by thelight sensor may decrease, and this may be indicated by a decrease inthe lux level of light captured by the light sensor. In anotherarrangement, the light captured by the light sensor may change in color,such as from a red light captured from a ‘new’ ground element, to apredominantly dull white light captured from a ‘to be replaced’ groundelement. In such arrangements, the light sensor may be configured tooutput a signal indicating the amount of light captured and/or thecondition of the disposable component. A controller may also beconfigured in conjunction to receive the signal from the light sensorand indicate to the patient that the disposable component may requirereplacement.

Optionally, in some cases a reminder of the need for replacement of thedisposable component may be presented on a display (e.g., LCD) of therespiratory apparatus. For example, a visible message may be presentedfor a user to indicate that a ground element should be replaced. Such amessage may be triggered by a processor of the apparatus, such as bytiming use of the flow generator (or timing use of an ionizer(s)) with atimer or count down timer and triggering the reminder after a lapse of apredetermined amount of time. Such a timer may be manually reset by theuser upon installation of the replacement component. In some cases, thereset may be triggered automatically by the respiratory apparatus upondetection of the replacement part (e.g., ground element). For example,the apparatus may detect the installation by detection of anidentification tag such as a radio frequency identification tag (RFID)of the ground element. In some cases, the component may be detected byany of the identification technologies described in U.S. Pat. No.7,913,689, the entire disclosure of which is incorporated herein bycross reference. Optionally, the presentation of the reminder may alsoor alternatively be triggered based on the evaluation involving thelight sensor as previously described.

FIG. 8 shows an example flow path of a flow generator that may include aseries of two or more ion generators along the flow path as illustrated.Selective activation or deactivation of the ion generators may becontrolled to increase or decrease a flow of breathable gas generatedwithin the flow path. For example, activation of a single ion generatormay propel a low flow or low pressure level of breathable gas. Byincreasing the number of activated generators along the path, which canpermit a pressure lock between each consecutive generator of the path,the flow (and thus, the pressure) propulsion may increase so as toimplement a cascade acceleration effect.

As illustrated the device 100 of FIG. 8 may also include one or more ofan optional filter 520, ground element 522, humidifier 524, tube sheetanodes 711 and/or a secondary ionizer 101-B in a similar arrangement tothat described above in relation to FIGS. 5 and/or 7. The device isconfigured to deliver the supply of pressurized, optionally humidified,ionized gas to a mask or patient interface 108.

The ion generators may be coupled to heating elements to provide heatedionized air to the user. The heating elements and ion generators may besurrounded by a wicking material that is configured to hold a supply ofwater that is humidified by the heating elements resulting in the supplyof a humidified heated ionized flow of air to the user. The wick andheating elements may be in the form of heating strips as described inUnited States Patent Application Publication No. 2010/0206308, filedJan. 10, 2010, the entire disclosure of which is incorporated herein byreference.

Control of the ion generators for such flow and/or pressure generationmay be in a closed or open loop control configuration. For example, thegenerated flow by activation of the ion generator(s) may be responsiveto measured system or patient characteristics from one or more sensor(s)890, such as any of the sensors previously mentioned or for example,flow and/or pressure sensors in a control loop utilizing flow and/orpressure measures. In some such cases, the number of ion generatoractivations by a controller 888 may increase or decrease until ameasured characteristic (e.g., a measured flow signal or measuredpressure signal) meets a target (e.g., set or desired target flow valueor pressure value). Changes to such flow or pressure may be made inaccordance with any known flow or pressure treatment control schemebased on detected patient characteristics such as from an analysis of apatient respiratory flow signal. In some of these examples, the flowgenerator may selectively produce varying levels of flow or pressure byselectively activating different numbers of ion generators. However, insome implementations, the flow propulsion to a respiratory interfacethat is generated from the group of ion generators may be varied byvarying an exhaust area, such as with an electro-mechanical exhaust ventor valve of the flow generator or respiratory interface, whilemaintaining the activation of the ion generators to be relativelyconstant.

Some example series implementations are illustrated in the ionizationflow generators of FIGS. 9a, 9b and 10. In FIG. 9a , sets of carbonfiber brush ionizers 101-CF may serve as a flow generator (FG).According to another instance of the present technology, each carbonfiber brush ionizer 101-CF may be further matched to a correspondingground plane 101-GP such as that shown in FIG. 9b . In this arrangement,the direction between the carbon fiber brush ionizer 101-CF and thecorresponding ground plane 101-GP may define the direction ofionization. This arrangement may allow for improved consistency in thedirection of ionization allowing improved control of the direction ofpropulsion of ionized air.

Preferably, the ground plane 101-GP is sufficiently close to thecorresponding ionizer, such as 101-CF, to allow ionization to occur.Conversely, the ground plane 101-GP should be sufficiently far from anyother ionizers 101-CF in order to prevent any unwanted ionization fromoccurring between any other pairs of ground planes and ionizers. Oneexample of a suitable arrangement of a ground plane 101-GP may be aconductive plate, for example made of a ferrous metal, although othermaterials and arrangements may be suitable. In some cases, the groundplane 101-GP may be connected to, or integrally formed with, a metalliccomponent of the flow generator FG such as the housing.

In FIG. 10, sets of honeycomb ionizers 101-HC may serve as a flowgenerator (FG). By selectively increasing the number of ionizers thatare activated in the flow conduit, such as by a controller, an increasein flow in the flow path (FP) may be induced. In some cases, the fiberbrushes or honeycomb ionizers 101-HC may be formed within or along aflow path, such as a conduit 1010. For example, as illustrated in FIG.9a an initial set of brushes may be grouped so as to surround a flowpath through which a flow of air may be generated. Additional sets maythen be serially configured further up the flow path in the direction ofthe arrow of flow path (FP). In the example of FIG. 10 individualhoneycomb cells are serially aligned along the flow path. However, insome cases, each such cell may be formed by a honeycomb array of ionizercells through which the flow of ionized air may be generated.

In the ionizer/flow generator examples of FIGS. 11-14, a series ofionizers may be formed in a grid or sheet configuration with a helicalor spiral flow configuration. Such a configuration may permit extendingof the flow path length for flow acceleration via multiple ionizerswhile minimizing layout space. For instance, each ionizer 101 may haveits cathode and anode arranged to accelerate the flow of breathable gasin a particular direction, such as the direction of ionization. Forexample, as illustrated in FIG. 11, one or more ionizer sheets 1101,with flow passages there through for a plurality of ionizers 101, may becoupled between first and second, flow structures, such as flow blocks1103-1, 1103-2. The flow blocks may employ conduits or flow paths toroute flow sequentially through the plurality of ionizers of the ionizersheet 1101. For example, the flow conduits or paths of the first andsecond flow structures may be combined on opposing sides of the ionizersheet 1101 as illustrated in FIG. 12 so as to form a helical or spiralflow path (FP) sequentially through each of the ionizers 101. Althoughthe ionizer sheet 1101 is illustrated as a discrete component, in someexamples one or more may be integrated with either or both of the blockstructures, such as on a surface thereof such as in the example of FIGS.13A, 13B 14A and 14B. Similarly, in some cases, ionizers may be locatedspirally, rather than in a common plane of the sheet, along a spiral orhelical flow path. Moreover, although the helical flow path isillustrated with block structures, it will be understood that suchpathways may be implemented with simple conduits or tubes making theappropriate series of connections with the ionizers.

In another arrangement according to the present technology, ionizers maybe used in a delivery conduit which comprises multiple tubes, such as adual-limb air delivery conduit shown in FIG. 15. The air deliverycircuit shown in FIG. 15 includes an inspiratory limb 1510 comprisingcarbon fiber brush ionizers 101-CF arranged in one orientation, and anexpiratory limb 1520 comprising carbon fiber brush ionizers 101-CFarranged in the opposite orientation. The carbon fiber brush ionizersmay be arranged to propel the inspiratory flow or the expiratory flowalong a desired direction.

In a yet another arrangement, ionizers may be used in an air deliveryconduit which comprises multiple channels in a tube as shown in FIG. 16a-18. FIG. 16a and FIG. 16b show an arrangement of the conduit formed asa tube 1610 with a divider DIV. In some cases, the divider DIV may beinserted to sealingly engage with the tube 1610 to create two or morechannels, such as an inspiratory channel 1620 and an expiratory channel1630. In other cases, the divider DIV may be integrally formed with thetube 1610.

The inspiratory channel 1620 and/or the expiratory channel 1630 maycomprise a set of ionizers, such as carbon fiber ionizers 101-CF asshown in FIGS. 16a and 16b . The ionizers 101-CF may be configured toaccelerate the flow of gas in the desired direction as previouslydescribed. According to some arrangements, the divider DIV may beconfigured as a ground element, or a part thereof, for the inspiratorychannel 1620 and/or the expiratory channel 1630. This may be potentiallyadvantageous by reducing complexity of the device, and potentially alsoreduce manufacturing costs. In some cases, the divider DIV may beremovably coupled to the tube 1610 to facilitate maintenance asdescribed above.

FIG. 17 shows an arrangement according to the present technology wherethe divider DIV is arranged helically in a cylindrical delivery tube110. In this arrangement, the ionizers such as carbon fiber brushionizers 101-CF may be configured along the walls, and arranged inconcert with the helical divider DIV to form a volute which may furtherincrease flow velocity, for instance by using the helical divider DIV asa ground element or a part thereof.

It should also be understood that the number of delivery conduits orchannels, as well as their flow directions, may be varied while takingadvantage of the present technology. For instance, the air deliveryconduit and divider arrangement shown in FIG. 17 may be used to providea flow of breathable gas travelling in only one direction, if sodesired.

In some cases, the flow generator FG may further comprise a humidifier.According to one arrangement, the flow generator FG may further comprisea wick to humidify the inspiratory flow. The divider may be arranged toincorporate one or more wicking strips and ancillary components, forexample similar to those described in PCT Application publication numberWO/2009/015410, the entire contents of which is incorporated herein byreference. Additionally, such a delivery conduit may be arranged toincorporate the ionizers in any number of arrangements. For instance, asshown in FIG. 18, the ionizers, 101-CF may be arranged on both sides ofa divider DIV, and the tube 1810 may be used as the ground element. Inanother example, a part or the entirety of the divider DIV may alsoinclude an exchanger for heat and/or moisture, for example as disclosedin PCT Application number PCT/AU2012/001382, the entire contents ofwhich is incorporated herein by reference.

While the solid state ionizer flow embodiments described herein may besuitable for generation of a flow of ionized air for an ionized airtherapy to be delivered to the respiratory system of a patient or user,in some embodiments the ionized airflow generated may be neutralized fordelivery to a patient or user substantially without an ion therapy. Forexample, a ground element or other neutralizing element 1201 may beimplemented at or following the flow output end of the ion flowgenerator to deionize the breathable gas. For example, in a case of ananion flow generator, one or more cathodes at the end of the series ofanion generators may be included to neutralize the air for patient oruser inhalation. Thus, the solid state ion flow generator may beimplemented for a pressure or flow treatment to a patient or userwithout providing significant ionized air therapy to the patient oruser.

Example System Architecture

An example system architecture of a controller suitable for implementingthe present pressure/flow and/or ionization therapy technology isillustrated in the block diagram of FIG. 6. In the illustration, thecontroller 601 for the ionization therapy device 100 may include one ormore processors 608. The device may also include a display interface 610to output pressure, event and/or ionization graphs (e.g., respiratoryevent vs. time curves, flow and/or pressure vs. time curves orionization level vs. time curves, such as those as illustrated in FIGS.3 and 4 or the like, etc.) as described herein such as on a monitor orLCD panel. A user control/input interface 612, for example, for akeyboard, touch panel, control buttons, mouse etc. may also be providedto activate or modify the control parameters or settings for themethodologies described herein. For example, these may be utilized forentering settings for ionization periods and ionization levels, safetylimits, etc., and/or for activation of the initiation of one or moretimed wake periods when a patient or user deems it necessary to fall orreturn to sleep during a session with the device. The device may alsoinclude a sensor or data interface 614, such as a bus, forreceiving/transmitting data such as programming instructions, flow data,ionization data, pressure data, settings for ionization level modulationetc. The device may also typically include memory/data storage 620components containing control instructions of the aforementionedmethodologies (e.g., FIGS. 2-4). These may include processor controlinstructions for sensor signal processing (e.g., physiologicalcharacteristic detection (e.g., cycle detection, respiratory phasedetection, sleep detection, arousal detection, sleep/awake statedetection, blood oxygen saturation detection, respiratory eventdetection, apnea detection, hypopnea detection, hypoventilationdetection, etc.,) pre-processing methods, filters, etc.) at 622 asdiscussed in more detail herein. They may also include processor controlinstructions for pressure/flow control and modulation (e.g., pressureadjustment equations, functions, and logic, trigger thresholds, eventthresholds, etc.) at 624. They may also include processor controlinstructions for ionization modulation (e.g., ionization leveladjustment equations, functions and logic, trigger thresholds, eventthresholds, ramp functions, change thresholds, timers, timingthresholds, etc.) at 626. Finally, they may also include stored data628, such as historic use data, for these methodologies such as pressuredata, flow data, ionization data, sleep data, respiratory event data,functions, tables, ionization settings, thresholds, timing periods,safety limits, other settings, etc.)

In some embodiments, the processor control instructions and data forcontrolling the above described methodologies may be contained in acomputer readable recording medium as software for use by a generalpurpose computer so that the general purpose computer may serve as aspecific purpose computer according to any of the methodologiesdiscussed herein upon loading the software into the general purposecomputer.

The present technology advantageously provides a device that provides aclean supply of air even in polluted locations as the air is cleaned bythe ionization and filtering process. Furthermore, by further ionizingthe air supply clean, antiseptic and ion latching air can be supplied tothe user. Thus, the device may be used in contaminated atmospheres toprovide at least clean air either with or without other therapies beingprovided. The device may also provide a supply of clean air using a lowpower consumption.

In the foregoing description and in the accompanying drawings, specificterminology, equations and drawing symbols are set forth to provide athorough understanding of the present technology. In some instances, theterminology and symbols may imply specific details that are not requiredto practice the technology. For example, although the terms “first” and“second” may be used herein, unless otherwise specified, the language isnot intended to provide any specified order but merely to assist inexplaining distinct elements of the technology. Furthermore, althoughprocess steps in the detection methodologies have been illustrated inthe figures in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted in parallel or synchronously. Moreover,although the features described herein may be utilized independently,various combinations thereof may be made in a respiratory pressuretreatment apparatus. Other variations can be made without departing withthe spirit and scope of the technology.

The invention claimed is:
 1. A solid state airflow generator of arespiratory apparatus for generating a controlled supply of air, thesolid state airflow generator comprising: a set of ionizers configuredto propel a flow of air, the set of ionizers configured with a flow pathadapted to couple with a user respiratory interface, wherein (a) theflow path is helical and the set of ionizers is arranged along thehelical flow path or (b) the flow path comprises a conduit and the setof ionizers is arranged in a series in the conduit; and a controllercoupled with the set of ionizers, the controller configured toselectively activate ionizers of the set of ionizers for propelling theflow of air, wherein the selectively activated ionizers propel the flowof air to generate a respiratory flow or pressure treatment toward or inthe user respiratory interface.
 2. The solid state airflow generator ofclaim 1 wherein the flow path includes a divider.
 3. The solid stateairflow generator of claim 2 wherein the divider separates two or morechannels and wherein each channel includes a subset of the set ofionizers.
 4. The solid state airflow generator of claim 3, wherein thechannels comprise an inspiratory channel and an expiratory channel. 5.The solid state airflow generator of claim 2 wherein the divider isconfigured as a ground element.
 6. The solid state airflow generator ofclaim 2 wherein the divider is arranged helically in a cylindricaldelivery tube.
 7. The solid state airflow generator of claim 2 whereinthe solid state airflow generator propels the flow of air without ablower.
 8. The solid state airflow generator of claim 2 wherein thesolid state airflow generator propels the flow of air substantiallywithout moving components.
 9. The solid state airflow generator of claim1 further comprising a sensor, wherein the controller is configured toactivate a sub-set of the set of ionizers based on a signal generatedfrom the sensor.
 10. The solid state airflow generator of claim 9wherein the sensor is a flow sensor, and wherein the controller isconfigured to selectively activate a sub-set of the set of ionizersbased on a measure of flow from a signal from the flow sensor.
 11. Thesolid state airflow generator of claim 9 wherein the sensor is apressure sensor, and wherein the controller is configured to selectivelyactivate a sub-set of the set of ionizers based on a measure of pressurefrom a signal of the pressure sensor.
 12. The solid state airflowgenerator of claim 9 wherein the sensor is a pressure sensor, andwherein the controller is configured to selectively activate a sub-setof the set of ionizers based on a measure of pressure from a signal ofthe pressure sensor to control a delivery of a treatment pressure. 13.The solid state airflow generator of claim 1 wherein the selectivelyactivated ionizers propel the flow of air to generate the respiratoryflow.
 14. The solid state airflow generator of claim 13 wherein therespiratory flow comprises a high flow treatment.
 15. The solid stateairflow generator of claim 1 wherein the selectively activated ionizerspropel the flow of air to generate the pressure treatment.
 16. The solidstate airflow generator of claim 15 wherein the pressure treatmentcomprises a continuous positive airway pressure (CPAP) treatment. 17.The solid state airflow generator of claim 1 wherein the set of ionizersis arranged in a serial configuration in the flow path and wherein thecontroller selectively activates an increasing number of ionizers of theset of ionizers to increase propulsion of the flow of air.
 18. The solidstate airflow generator of claim 1 wherein the set of ionizers comprisesan ionizer sheet.
 19. The solid state airflow generator of claim 1wherein the flow path is helical and the set of ionizers is arrangedalong the helical flow path.
 20. The solid state airflow generator ofclaim 1 further comprising a neutralizer, the neutralizer configured todeionize the propelled flow of air of the flow path.
 21. The solid stateairflow generator of claim 1 wherein the set of ionizers comprises aplurality of carbon fiber brush ion generators.
 22. The solid stateairflow generator of claim 1 wherein the set of ionizers comprises aplurality of honeycomb cell ion generators.
 23. The solid state airflowgenerator of claim 2 wherein the divider is configured for removablycoupling within the conduit.
 24. The solid state airflow generator ofclaim 1 wherein the flow path comprises the conduit and the set ofionizers is arranged in a series in the conduit.
 25. A solid stateairflow generator of a respiratory apparatus for generating a controlledsupply of air, the solid state airflow generator comprising: a set ofionizers configured to propel a flow of air, the set of ionizersconfigured with a flow path adapted to couple with a user respiratoryinterface, wherein (a) the flow path is helical and the set of ionizersis arranged along the helical flow path or (b) the flow path comprises aconduit and the set of ionizers is arranged in a series in the conduit;and a controller coupled with the set of ionizers, the controllerconfigured to selectively activate ionizers of the set of ionizers forpropelling the flow of air, wherein the set of ionizers is arranged in aserial configuration in the flow path and wherein the controllerselectively activates an increasing number of ionizers of the set ofionizers to increase propulsion of the flow of air.